Principal Scientist, QC Development & Life Cycle

Job Title:      Principal Scientist, QC Development & Lifecycle

Location:      Columbus, OH 

Job Type:     Full time

Req ID:         11184

 

About Us:  

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Scientist IV, QC Development & Lifecycle to join our team.  

In this role, you will be responsible for Managing highly technical analytical projects in support of new products analysis, development and validation in order to facilitate a consistent and compliant approach.  Conducts analytical method development, testing and validation in support of regulatory submissions and new product launches. Provides peer leadership, mentoring and decision-making for various laboratory studies in support of ANDA/NDA applications and/or application updates (validation, verification, equivalency, etc.).

 

Key Responsibilities:

• Develops with little to no supervision and validates analytical procedures to meet SOPs, ICH, JP, EP, USP, EMEA, and FDA requirements; performs analytical transfers for multi-source and brand products internally and externally.  Organizes study data to assist/write technical reports.
• Takes the lead on assigned highly technical projects with little to no supervision to facilitate analytical method development, testing, validation and project support for alternative API and business development projects.  Using project planning tools, identifies, offers, and implements contingency plans to prevent and overcome analytical issues and perform analytical procedure trouble shooting with little to no supervision.
• Performs qualitative, quantitative, developmental, chemical and physical testing for highly technical projects as specified by compendia (USP, JP, BP), regulatory authority (FDA & ICH) for starting materials, packaging components, intermediates and finished products.
• Follows work instructions, SOPs, company practices and regulatory guidances/regulations. Documents analytical activities and results accurately, in a timely manner and right-first time.  Reviews and checks analytical data generated by peers and maintains integrity of data.  Supports activities to maintain the laboratory status of compliance to FDA/regulatory standards.
• Proactively participates in activities in support of process changes (e.g. processes, procedures, etc...).   Suggests and leads process improvements to refine current systems and improve efficiency. Mentors peers in method development, validation, troubleshooting, instrumentation, laboratory practices, and processes.  Conducts trainings on selected topics of interest for the department
• Communicates effectively with peers, supervisor, management and internal/external customers about project status.  Monitors project status and proactively communicate to supervisor potential delays and challenges, along with a path forward.  Participates and represents the department in cross-functional teams.

 

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• B.S degree and Ten (10) years of laboratory experience in a pharmaceutical or highly regulated environment.
• M.S. degree and Six (6) years of laboratory experience in a pharmaceutical or highly regulated environment.
• For Ph.D. degree and Five (5) years of laboratory experience in a pharmaceutical or highly regulated environment.
• Must possess a specialized knowledge of ICH and FDA guidances, technolo